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Latest Guide to Chinese Pharmaceutical GMP Regulations
Latest Guide to Chinese Pharmaceutical GMP Regulations provides a
comprehensive and thorough knowledge of the Chinese pharmaceutical GMP
regulations to guide overseas pharmaceutical companies and multinational
pharmaceutical companies to achieve a successful entry into the Chinese
lucrative drug market and help overseas pharmaceutical companies and
multinational pharmaceutical companies to make decisions on entry into the
Chinese lucrative drug market.
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Summary
China possesses a fourth population in the world and has one of the largest drug markets round the
world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion)
reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of
Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as
an increasingly ageing population, accelerating growth of urban population as well as expansion of
healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20
percent per annum in next three years. China is expected to become the second largest drug market in
the world by 2015.
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Table Of Content
Chapter 1 Introduction.. 5
Chapter 2 An Overview of Good Manufacturing Practice (GMP) for Drugs..11
2.1. General..11
2.2. Glossary 11
2.3. Quality Management..16
2.4. Organization and Personnel...19
2.5. Premises and Facilities..25
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Chapter 3 Good Manufacturing Practice for Sterile Pharmaceutical Products.. 75
3.1. Scope of Application. 75
3.2....